FDA Approves New Constipation Drug

Susan Farley

Published Online: Saturday, April 1, 2006

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A new prescription drug, lubiprostone
(Amitiza), has been approved for the treatment
of chronic idiopathic constipation in
adults. This capsule form of lubiprostone
increases the secretion of intestinal fluid,
which then eases the passage of stool
and alleviates constipation symptoms.
Two clinical trials were conducted to test
the drug's efficacy. Patients participating
in the trial had had, on average, fewer
than 3 spontaneous bowel movements
per week and had experienced symptoms
of constipation for at least 6
months. In the trials, lubiprostone yielded
a higher frequency of bowel movements
in the first week than the placebo. Similar
results continued for weeks 2, 3, and 4.
Studies over 6 to 12 months showed
that the drug decreased constipation
severity, abdominal bloating, and discomfort.
Common side effects of
lubiprostone were headache, nausea,
diarrhea, abdominal pain, and distention,
which may or may not be associated
with the drug. It is being marketed by
Sucampo Pharmaceuticals and Takeda
Pharmaceuticals America.